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Clinical Trials/IRCT20220111053692N7
IRCT20220111053692N7Not yet recruiting未知

Bioequivalence study of Gliclazide 60 mg Extended Release Tablet (Tehran Chemie) versus Diamicron MR (SERVIER) Tablet after single oral dosing in healthy volunteers

Tehran Chemie Pharmaceutical Company0 sites24 target enrollmentStarted: TBDLast updated:
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Trial Snapshot

Phase
未知
Status
Not yet recruiting
Sponsor
Enrollment
24
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 years to 55 years (—)
Sex
Male

Inclusion Criteria

  • •18 to 55 years old
  • •Weight in range of 10 % proper body weight
  • •All volunteers should be in a good health condition on the basis of medical history ,physical examination , routine blood test.
  • •Possessing negative test for hepatitis B surface antigen (HBs-Ag), Antihepatitis-C antibody (anti-HCV) and anti-HIV.

Exclusion Criteria

  • •Volunteers with hypersensitivity to Gliclazide were excluded.
  • •Those with known history of drug abuse. alcohol consumer or cigarette smokers.
  • •Taking medications that have drug interactions with gliclazide until one month before studying.
  • •disinclination to take the test.
  • •Blood donation or blood loss of more than 200 ml in the past month.

Investigators

Sponsor
Tehran Chemie Pharmaceutical Company

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